UMIN-CTR Clinical Trial

Public title

Investigation of the efficacy and safety of ipragliflozin combination therapy in case of insufficient glycemic control by DPP-4 inhibitors

Acronym

Investigation of the efficacy and safety of ipragliflozin combination therapy in case of insufficient glycemic control by DPP-4 inhibitors

Scientific Title

Investigation of the efficacy and safety of ipragliflozin combination therapy in case of insufficient glycemic control by DPP-4 inhibitors

Scientific Title:Acronym

Investigation of the efficacy and safety of ipragliflozin combination therapy in case of insufficient glycemic control by DPP-4 inhibitors

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the influences of hypoglycemic effect and body weight in patients with poorly controlled type 2 diabetes whereas undergoing DPP-4 inhibitor treatment

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in HbA1c from baseline to 24 weeks

Key secondary outcomes

Change in following items from baseline to 12 and 24 weeks

1) HbA1c (Except for 24 week), GA
2) Body weight
3) Fasting plasma glucose
4) Serum insulin (HOMA-beta, HOMA-R) and serum C-peptide
5) Waist circumference (Except for 12 week)
6) Blood pressure and heart rate
7) Uric acid
8) Serum cystatin C (Except for 12 week)
9) Serum lipids (TC, LDL-C, HDL-C, and TG)
10) RLP-C (Remnant like particles cholesterol) (Except for 12 week)
11) ApoB, ApoA-1, ApoB/ApoA-1 ratio (Except for 12 week)
12) Thioredoxin-interacting protein (TXNIP) (Except for 12 week)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 24 weeks

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Aged 20 to 80 years at providing consent
2) Poorly glycemic controlled patients nevertheless who undergoes DPP-4 inhibitors at least 12 weeks
3) HbA1c >= 6.5 and < 9.5%
4) BMI >= 22 kg/m2
5) Received informed consent

Key exclusion criteria

1) Type 1 diabetes
2) With severe ketosis, diabetic coma, or precoma
3) With severe infection, pre or post surgery, and serious trauma
4) With severe hepatic dysfunction (Over grade 3 in classification criteria for severity of adverse drug reactions)
5) With moderate or severe renal dysfunction (Serum Creatinine male: >= 1.5mg/dL, female: >= 1.3mg/dL)
6) Has stroke, myocardial infarction, or other serious cardiovascular complications requireing hospitalization within 6 months
7) Is receiving SGLT-2 inhibitors, GLP-1 antagonists, or insulin therapy at consent
8) Is nursing or pregnant or planned to become pregnant
9) With hypersensitivity to ipragliflozin or any other excipient of ipragliflozin
10) Considered as inadequate by the investigator

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Kenji Furukawa

Organization

Japan Community Health care Organization Kanazawa Hospital

Division name

internal

Zip code

Address

Ha-15, Oki-machi, Kanazawa-city, Ishikawa, Japan

TEL

076-252-2200

Email

kenjif-knz@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Kenji Furukawa

Organization

Japan Community Health care Organization Kanazawa Hospital

Division name

internal

Zip code

Address

Ha-15, Oki-machi, Kanazawa-city, Ishikawa, Japan

TEL

076-252-2200

Homepage URL

Email

kenjif-knz@umin.ac.jp

Institute

Japan Community Health care Organization Kanazawa Hospital

Institute

Department

Personal name

Organization

Astellas Pharma Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

08

Month

07

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

07

Month

10

Day

Date of IRB

Anticipated trial start date

2014

Year

08

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

08

Month

07

Day

Last modified on

2016

Year

10

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017196